Influenza vaccine manufacturers in the EU must file strain variation applications for next year’s flu season with the European Medicines Agency (EMA) by June 16. Filings must comport with newly adopted strain variations recommended by the World Health Organization, the EMA said.
A trivalent vaccine for the 2014/2015 flu season should contain the following strains:
The A/California/7/2009 (H1N1) pdm09-like virus;
The A/Texas/50/2012 (H3N2)-like virus; and
The B/Massachusetts/2/2012-like virus.
That strain combination would also work for live attenuated influenza vaccines, the agency says.
In addition, manufacturers considering use of a B/Victoria/2/87 lineage as part of a quadrivalent vaccine with two type B viruses should use the B/Brisbane/60/2008-like virus in addition to the three aforementioned strains, the EMA recommends.
The agency adds that the National Institute for Biological Standards and Control will continue to supply reagents to standardize vaccine manufacturing.
The recommendations follow a notice published by the EMA earlier this year relieving drugmakers from conducting pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. However, beginning that same season, all makers of vaccines in the EU will be required to establish a risk management plan for their seasonal products.
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